Spots Global Cancer Trial Database for Clinical Trial of Yiqi Wenyang Jiedu Prescription in the Prevention and Treatment of Postoperative Metastasis and Recurrence of Gastric Cancer
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Trial Identification
Brief Title: Clinical Trial of Yiqi Wenyang Jiedu Prescription in the Prevention and Treatment of Postoperative Metastasis and Recurrence of Gastric Cancer
Official Title: Yiqi Wenyang Jiedu Prescription in the Prevention and Treatment of Postoperative Metastasis and Recurrence of Gastric Cancer：A Randomized, Double-blind, Controlled and Multi-center Clinical Study
Study ID: NCT05229809
Conditions
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of Yiqi Wenyang Jiedu prescription for postoperative gastric cancer.
Detailed Description: This study include a multicenter, randomized, double-blind, placebo, parallel controlled clinical trial.The randomized clinical trial will enroll approximately 212 patients. Participants will be randomly divided into experimental (n=106) and control groups (n=106).Patients in the experimental group was treated with Yiqiuyang Jiedu prescription within 6-8 months after radical gastroctomy and after the completion of standard regimen (XELOX and SOX) for at least 6 cycles of adjuvant chemotherapy. Patients in the control group will receive the placebo.The primary endpoint is 2-year DFS (Disease-free survival) rate after surgery, that refers to the proportion of patients who do not have recurrence, metastasis or death (from any cause) within 2 years after surgery. The research protocol was approved by the relevant ethics committees, and the study was conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Patients gave written informed consent to participate in the trial.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, China
Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, Beijing, China
Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, Beijing, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China
Jiangsu Hospital of Traditional Chinese Medicine, Nanjing, Jiangsu, China
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, Shanghai, China
Contact Details
Name: Jie Li, Professor
Affiliation: Guang 'anmen Hospital, China Academy of Chinese Medical Sciences
Role: STUDY_DIRECTOR
Name: Yu Wu, Professor
Affiliation: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Role: PRINCIPAL_INVESTIGATOR
Name: Shijie Zhu, Professor
Affiliation: Wangjing Hospital, China Academy of Chinese Medical Sciences
Role: PRINCIPAL_INVESTIGATOR
Name: Hong Zhao, Professor
Affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Role: PRINCIPAL_INVESTIGATOR
Name: Lizhu Lin, Professor
Affiliation: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Role: PRINCIPAL_INVESTIGATOR
Name: Ling Xu, Professor
Affiliation: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine
Role: PRINCIPAL_INVESTIGATOR
Name: Peng Shu, Professor
Affiliation: Jiangsu Hospital of Traditional Chinese Medicine
Role: PRINCIPAL_INVESTIGATOR
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